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Peritoneal AdhesionsNCT02847676

Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery

An observational study of Peritoneal Adhesions, run by Pius-Hospital Oldenburg.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Peritoneal Adhesions
What is being tested?
Tissue sample donation
Type of treatment
Surgery or procedure
How many people
40 participants
Where
No sites listed yet
Study dates
Aug 2016to Aug 2017
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All patients undergoing scheduled pelvic gynecological surgical treatment, at the Gynecology Department of Pius Hospital, Oldenburg.

Who may be able to join

  • Woman equal to and above 18 years of age.
  • Woman with a negative pregnancy test at the time of recruitment, and sufficient contraception from time of
  • Woman with any gynecological pathology requiring scheduled pelvic gynecological surgery, either laparotomy or laparoscopy.
  • Woman without primary peritoneal disease.

Who cannot join

  • Woman with a primary peritoneal pathology.
  • Emergency surgery
  • Patients under systemic immunosuppressive therapy in the previous 6 months
  • Patients with current intra-abdominal or pelvic abscess or systemic infection
  • Pregnant woman
  • Simultaneous participation in another clinical trail

Trial locations and contacts

No sites are listed yet.

Rudy Leon De Wilde, Prof. dr. dr. med contact

0441 2291501

gyn-sekretariat@pius-hospital.de

About this study

Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency.

Read the detailed description

Peritoneal adhesions are connective tissue bands between two normally separate anatomical structures within the abdominal or pelvic cavity. Those adhesions can occur after gynaecological or other surgeries involving the pelvis or abdomen. Adhesions have severe clinical as well as economical Consequences. There is substantial morbidity (from chronical pain to obstructions and infertility) and a higher surgical risk if additional surgery is needed, due to a higher intraoperative blood loss and a higher incidence of lacerations when peritoneal adhesions are present. In combination with a prolonged surgery duration, the economical impact is tremendous. A 2011 study estimated the cost of adhesion - related surgeries to be 2,3 billion US dollar exclusively in the USA. 46.3% of those surgeries had their origin or localisation in the gynaecological area. The genesis of adhesiolysis - obligatory peritoneal adhesions remains unclear to this date.

After all surgeries cytokine induced fibrotic bands appear within 72 hours. Usually those bands are eliminated by a fibrinolytic sequence within 10 days.

For Adhesions that persist afterwards the generally accepted assumption is, that there is a failure of the fibrinolytic sequence with unknown origin. Adhesions which persist for more than 10-14 days become thicker and vascularised. In those "adult" adhesions not only fibrin is found but also fat tissue, smooth muscles and myelinised and un - myelinised axons.

In developmental biology those tissues differentiate from different germ layers, namely mesoderm and ectoderm. Finding cells from multiple germ layers points towards a pluri -, multi-, or stem cell like precursor cell from which those adhesions develop. Such a cellpopulation has not been characterised in the abdomen to the date of writing, though Studies have shown evidence (ranging from mesothelial - to - mesenchymal shift to Clusters of differentiation from multiple germ layers) which made multiple researchers postulate a pluripotent precursor cell located in the submesothelium.

In our research we will therefore take peritoneal samples from adhesions, peritoneal wall lining and omentum in subjects with and without peritoneal adhesions in subjects undergoing indicated laparoscopic surgery at the gynaecological ward at the Pius hospital in Oldenburg.

The samples are routinely taken as part of the procedure and usually discarded. At least 24 hours prior to surgery, the subjects will have a chance to give their informed consent to donate those samples for our study. The study is thus designed in a way that subjects won't undergo additional risk by participating in the study. Taking part or the refusal hereof won't have any effect on the treatment or surgical outcome for the subjects. Also, taking part in our study won't have any benefits or additional risks for the subjects.

The samples will then be taken to the university of Leipzig, where we will culture, isolate and characterise the cells. Characterisation will mostly be the application of pluripotency markers, cell sorting and immunoassays. Expression profiles will be used to further understand the mesothelial - to - mesenchymal shift. Depending on our findings the protocol for analysis will be adjusted in consultation with Prof. dr. dr. De Wilde and Prof. dr. Bader.

The study will approximately take 6 months, with an additional 6 months for writing and publication. The study is funded by the research funding pool of the university of Oldenburg.

Being tested
Tissue sample donation
Keywords
Peritoneal adhesions, Stem cells, MSC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tissue sample donationProcedure or surgery

    Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated.

Study groups in NCT02847676
Study groupRoleWhat they receive
No previous surgery, adhesions present.Patients have had no previous abdominal surgery. Inspection shows peritoneal adhesions.
Receives: Procedure: Tissue sample donation
No previous surgery, no adhesions present.Patients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions.
Receives: Procedure: Tissue sample donation
Previous surgery, adhesions present.Patients have had previous abdominal surgery. Inspection shows peritoneal adhesions.
Receives: Procedure: Tissue sample donation
Previous surgery, no adhesions present.Patients have had previous abdominal surgery. Inspection shows no peritoneal adhesions.
Receives: Procedure: Tissue sample donation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)

    days since previous surgery

    Measured: at least 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJan 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
40 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847676
Sponsor's protocol ID
PHDW-005
Status last verified
Jul 2016
First submitted
25 Jul 2016
Last updated
28 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peritoneal Adhesions, run by Pius-Hospital Oldenburg.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rudy Leon De Wilde, Prof. dr. dr. med (0441 2291501, gyn-sekretariat@pius-hospital.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4) (time frame: at least 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.

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